BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 10638787 · Received October 6, 2020

    Report

    Report Number
    1710034-2020-00646
    Event Type
    Death
    Date Received
    October 6, 2020
    Date of Event
    September 7, 2020
    Report Date
    October 12, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED CATHETER ADAPTER ASSEMBLY AND SIX PHOTOS. SINCE NO SPECIFIC DEFECT WAS REPORTED, BD PERFORMED A THOROUGH INSPECTION OF THE UNIT AND ITS COMPONENTS WHICH INVOLVED INVESTIGATING POTENTIAL DEFECTS INVOLVING THE ADAPTER, CATHETER, SEPTUM, AND ACTUATOR. VISUAL INSPECTION OF THE DEVICE AND PHOTOS WERE PERFORMED. IT WAS OBSERVED THAT THE ACTUATOR WAS PUSHED THROUGH THE SEPTUM AND DRIED MEDIA WAS PRESENT AROUND THE SEPTUM AND BASE INDICATING THAT FLOW SUCCESSFULLY OCCURRED. THROUGH MICROSCOPIC EXAMINATION OF THE CATHETER TUBING, NO DAMAGED TO THE CATHETER TUBING WAS OBSERVED. THE CATHETER TIP WAS INSPECTED AND DETERMINED TO BE ACCEPTABLE. THE FUNCTIONAL TEST FOR LEAKAGE WAS CONDUCTED AND NO LEAKAGE WAS OBSERVED. FINALLY, THE ACTUATOR AND SEPTUM WERE INSPECTED AND NO DAMAGE WAS OBSERVED. THE RETURNED UNIT PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. BD WAS UNABLE TO IDENTIFY ANY DEFECTS. DHR WAS PERFORMED. NO SPECIFIC DEFECT WAS IDENTIFIED BY THE CUSTOMER AND NO DEFECT WAS FOUND DURING THE INVESTIGATION, THEREFORE NO COMMENT CAN BE MADE ON WHETHER PROCESS DEVIATIONS OR QUALITY ISSUES THAT OCCURRED DURING MANUFACTURING OF THE AFOREMENTIONED LOTS WERE RELATED TO THIS DEFEC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN WAS INDWELLED IN A PATIENT WHEN THEY DIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BDJ WAS ASKED BY THE CUSTOMER TO INVESTIGATE WHETHER THE PRODUCT WAS DAMAGED OR NOT. THE DETAILS WILL BE REPORTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. 16TH SEPT 2020 NEW INFORMATION RECEIVED. (B)(6). THE PATIENT USED THIS PRODUCT WAS DEAD. DATE OF DEATH IS NOT REPORTED. THE CUSTOMER ASKED US TO PERFORM INVESTIGATION TO SEE IF THE PRODUCT IS WITHIN SPECIFICATION. NO OTHER INFORMATION IS RECEIVED AS OF TODAY. 21ST SEPT, 2020 (B)(6). THE SALES REP RECEIVED FOLLOWING INFORMATION. DATE OF DEATH: (B)(6) 2020. SEX: MALE. AGE: 70S. PRIMARY DISEASE: GASTRIC CANCER. HISTORY: AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION IS DONE, THE PATIENT SUDDENLY WENT INTO CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION WAS DONE THOUGH THE PATIENT WAS DEAD."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN WAS INDWELLED IN A PATIENT WHEN THEY DIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BDJ WAS ASKED BY THE CUSTOMER TO INVESTIGATE WHETHER THE PRODUCT WAS DAMAGED OR NOT. THE DETAILS WILL BE REPORTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ON 16TH SEPT 2020 NEW INFORMATION RECEIVED. (B)(6) THE PATIENT USED THIS PRODUCT WAS DEAD. DATE OF DEATH IS NOT REPORTED. THE CUSTOMER ASKED US TO PERFORM INVESTIGATION TO SEE IF THE PRODUCT IS WITHIN SPECIFICATION. NO OTHER INFORMATION IS RECEIVED AS OF TODAY. 21ST SEPT, 2020 (B)(6). THE SALES REP RECEIVED FOLLOWING INFORMATION. DATE OF DEATH: (B)(6) 2020. SEX: MALE. AGE: 70S. PRIMARY DISEASE: GASTRIC CANCER. HISTORY: AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION IS DONE, THE PATIENT SUDDENLY WENT INTO CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION WAS DONE THOUGH THE PATIENT WAS DEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097714 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death